Memantine Hydrochloride

ANDA 202350, held by Strides Pharma. Memantine Hydrochloride.

As of Nov 15, 2026, ANDA 202350 (Memantine Hydrochloride), held by Strides Pharma, was first approved by FDA on May 23, 2017, with 1 approved supplement and 0 published complete response letters.

First approved: May 23, 2017
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
May 23, 2017	Original application	Approved	None posted

Products

2 strengths and forms


Memantine Hydrochloride5MG · tablet;oral	Memantine Hydrochloride	Discontinued
Memantine Hydrochloride10MG · tablet;oral	Memantine Hydrochloride	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Apr 10, 2020	Supplement 1Labeling · Standard review	Approved	None posted
May 23, 2017	Original application	Approved	None posted

Identifiers

Application: ANDA 202350
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters